BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCS COMPLETE FEM POR L LG

    MDR report key: 1572084 · Received January 5, 2010

    Report

    Report Number
    1818910-2009-07764
    Event Type
    Injury
    Date Received
    January 5, 2010
    Date of Event
    December 7, 2009
    Report Date
    December 7, 2009
    Manufacturer
    DEPUY (IRELAND)
    Product Code
    NJL
    PMA / PMN Number
    P830055/S105
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PATIENT REVISED FOR INFECTION IN BILATERAL KNEES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCS COMPLETE FEM POR L LG 87NJL NJL DEPUY (IRELAND) NA 2209385

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention